Streptococcus pneumoniae is a common bacteria and major cause of serious infections like bloodstream infections, pneumonia, and meningitis. These infections are most common in children under 2 years old and adults over 65 years of age and dangerous for all age groups. Current vaccines, which contain parts of the bacteria, have significantly reduced the incidence of invasive pneumococcal disease (IPD). To broaden protection more serotypes are added to the vaccines over the years, which results in lower immune responses to the serotype-specific polysaccharides while a stronger vaccine is desired for older people and people with a weakened immune system. In addition, these complex vaccines are hardly affordable for the growing group of older adults in low- and middle-income countries (LMICs). To address these challenges, a new potent adjuvant called 'LiteVax Adjuvant' was developed. It has been shown to improve the efficacy of vaccines, even at low doses of antigen. A lower antigen dose reduces the costs of vaccines and promotes accessibility in LMICs. By testing a standard and a low dose of a commercial pneumococcal conjugate vaccine combined with LiteVax Adjuvant in healthy volunteers, we aim to determine whether the adjuvant enhances the immune response and if a lower vaccine dose is effective. At the same time, the safety of the vaccines is being investigated.
Written signed informed consent obtained before any study-related activities.
Aged 18 to 50 years inclusive, at the time of signing the ICF.
Participants who are considered to be in good general health as determined by medical evaluation including medical history, physical examination (PE) and laboratory tests within 21 days prior to enrolment.
Participants with a BMI within the range 18.5 to 35 kg/m2 inclusive at screening.
History of laboratory confirmed pneumococcal infection in the past 36 months prior to the day of study vaccination.
Positive (in the past, suspected or ongoing) for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) antibody.
Past or current history of immune-mediated and/or autoimmune diseases as indicated by the investigator, e.g. diabetes mellitus type I and thyroid disease.
Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the investigator.
Parallel
PCV-LITE
Biological/VaccineFractional dose of pneumococcal polysaccharide conjugate vaccine without LiteVax Adjuvant (LVA)
PCV-LITE+LVA
Biological/VaccineFractional dose of pneumococcal polysaccharide conjugate vaccine with 1 mg of LiteVax Adjuvant (LVA)
PCV20
Biological/VaccineStandard (full) dose of pneumococcal polysaccharide conjugate vaccine without LiteVax Adjuvant (LVA)
PCV20+LVA
Biological/VaccineStandard (full) dose of pneumococcal polysaccharide conjugate vaccine with LiteVax Adjuvant (LVA)
Solicited and non-solicited local and systemic adverse events after a single administration of Prevenar 20 with or without LiteVax adjuvant
To evaluate the safety and tolerability of a single administration of 1/5th-dose of Prevenar 20 + 1 mg LVA (PCV-LITE), 1/5th-dose of Prevenar 20 without LVA, and a full-dose of Prevenar 20 + 1 mg LVA in comparison to a full-dose of Prevenar 20 without LVA, in healthy participants (18-50 years) * Occurrence of solicited local and systemic adverse events (AEs) for 14 days, unsolicited AEs for 28 days, and serious adverse events (SAEs), potential immune-mediated diseases (pIMDs), and adverse events of special interest (AESIs) for 180 days after vaccination. * Occurrence of clinically abnormal haematology and serum biochemistry laboratory values 1 day, 7 days, and 28 days, after vaccination versus baseline (Day 0, pre-vaccination).
Humoral immune responses to a single administration of Prevenar 20 with or without LiteVax Adjuvant by multiplex immune assay (MIA)
Humoral immune responses to low and full dose of Prevenar 20 with or without LiteVax Adjuvant (LVA) will be determined by a validated multiplex immune assay (MIA) in individual serum samples and expressed as arbitrary units. Geometric mean titers (GMTs), geometric mean concentrations (GMCs), standard deviation (SD), and 95% confidence intervals (95% CI) against the 20 vaccine serotypes will be calculated per cohort.
Humoral immune response to a single administration of Prevenar 20 with or without LiteVax Adjuvant measured by opsonophagocytic activity assay (OPA)
Humoral immune response to low and full dose of Prevenar 20 with or without LiteVax Adjuvant will be determined by a validated opsonophagocytic activity assay (OPA) in individual serum samples and expressed as arbitrary units. Geometric mean titers (GMTs), geometric mean concentrations (GMCs), standard deviations (SDs), and 95% confidence intervals (95% CIs) against the 20 vaccine serotypes or a selection thereof) will be calculated per cohort
Functional serum antibody responses
Functional serum antibody responses to (a selection of) the 20 serotypes of PCV20 will be determined by validated .
Mucosal antibody response
Mucosal (IgG and/or IgA) antibody titers in nasal swabs to (a selection of) the 20 serotypes of PCV20 will be determined by a validated multiplex immune assay (MIA) and expressed as arbitrary units.
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